• RoundupsRoundups

    Euro Roundup: France posts guidance on developing drug shortage management plans

    The French National Agency for Medicines and Health Products Safety (ANSM) has released guidance on the development of shortage management plans for drugs of major therapeutic interest.   In March, France published a decree to establish an obligation for pharmaceutical companies to have buffer stocks of medicines to mitigate the risk of shortages. The amount of stock companies need to carry depends on the importance of the drug. France will require manufacturers of dru...
  • Regulatory NewsRegulatory News

    USP, NIST and NIIMBL collaborate to boost viral vector quality standards

    A new public-private collaborative among the United States Pharmacopeia (USP), the US Department of Commerce’s National Institute of Standards and Technology (NIST) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) pools the expertise or the organizations to develop better measurement tools to assess the quality of adeno-associated virus (AAV), an increasingly important vector for gene therapy delivery.   According to a 27 June ann...
  • ReconRecon

    Recon: Emergent to resume J&J vaccine production; Sanofi raises profit forecast

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Citing New Data, Pfizer Outlines Case for Booster Shots ( NYTimes ) J&J says US FDA agrees to extend shelf life of its COVID-19 vaccine ( Reuters ) Emergent to resume J&J COVID-19 vaccine production at Baltimore plant ( Reuters ) ( WSJ ) U.S. House panel seeks J&J documents on baby powder bankruptcy plans ( Reuters ) AstraZeneca CEO hopeful COVID-19 vaccine m...
  • Regulatory NewsRegulatory News

    FDA approves Semglee as first biosimilar interchangeable insulin

    The US Food and Drug Administration (FDA) has approved the first interchangeable biosimilar product, giving the designation to a once-daily insulin product to treat diabetes.   FDA’s designation of Semglee (insulin glargine-yfgn, Mylan) as interchangeable with Lantus (insulin glargine, Sanofi) means that Semglee may now be substituted for the reference product at the pharmacy “without the intervention of the prescriber,” noted FDA in a Wednesday evening press release ...
  • RoundupsRoundups

    FDA Approvals Roundup: Bydureon, Dalvance, Shingrix

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New indications Bydureon use extended for type 2 diabetes in adolescents AstraZeneca’s Bydureon and Bydureon BCise (exenatide extended-release injection) have received expanded indications for improving glycemic control in children aged 10 years or older with type 2 diabetes.   The approval was based on effectiveness and safety findings from a 24-week, d...
  • Regulatory NewsRegulatory News

    Digital health collaborative aims to build in equity and inclusion

    A newly minted collaborative of industry, government, and patient groups is seeking to develop a set of best practices that will help make digital health measurement technologies work for all users, regardless of gender, race, ethnicity, and other factors.   The Digital Health Measurement Collaborative Community ( DATAcc ), launched in May 2021, is hosted by the nonprofit Digital Medicine Society (DiMe) and brings together more than 30 organizations, including the US F...
  • Feature ArticlesFeature Articles

    Regulatory considerations for real-world research studies in Europe

    Real-world research studies are a valuable source of real-world evidence (RWE). In Europe, successful deployment of these studies is dependent on identifying, understanding, and demonstrating which regulations are not applicable, as well as identifying (and complying with) the regional (Europe Union) and national requirements that are applicable.   Introduction The European Medicines Agency (EMA) recently called for high-quality observational research of real-world...
  • ReconRecon

    RECON: FDA halts Pepaxto trials; Pfizer nears $8B in vax sales for Q2

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer sells $7.8 billion in Covid shots in the second quarter, raises 2021 guidance on vaccine sales ( CNBC ) AstraZeneca castoff draws $123M wager on CXCR2 antagonist as Arena lines up a buyout option ( Endpoints ) Opinion: US FDA Should Take Its Time With COVID Vaccine BLAs ( Pink Sheet ) Biden Is Considering A Vaccine Or Testing Mandate For Federal Workers...
  • Regulatory NewsRegulatory News

    FDA sets deadline for study data technical rejection criteria

    The US Food and Drug Administration (FDA) has set a deadline for when it will begin refusing to file or to receive electronic submissions that fail to meet the agency’s established electronic common technical document (eCTD) validation criteria.   Beginning 15 September 2021, FDA says it will “reject submissions that contain any high validation errors included in the [technical rejection criteria] TRC.” The new effective date for the technical rejection criteria was an...
  • Regulatory NewsRegulatory News

    EMA addresses comparative quality assessment methods

    An updated reflection paper from the European Medicines Agency (EMA) tackles how statistics should be used in drug development when a comparative assessment of quality attributes needs to be made.   The paper touches on issues that arise both in the development of small molecules and in work being done in the area of biosimilars, where tricky manufacturing challenges and mutable organic molecules make defining the concept of “similarity” a challenge.   EMA’s human ...
  • Regulatory NewsRegulatory News

    ICH releases widely anticipated guidance on continuous manufacturing

    The International Council for Harmonisation (ICH) on Tuesday issued its Q13 guideline on continuous manufacturing, making a draft available for public comment.   The long-awaited draft was soon expected, according to an FDA official who gave an update on the status of the guideline at a 14 July CMC Strategy Forum sponsored by the California Separation Science Society (CASSS). (RELATED: Long-awaited ICH continuous manufacturing guideline coming soon , Regulatory Foc...
  • Regulatory NewsRegulatory News

    FDA’s revised MAPP outlines procedures for generic drug labeling changes

    The US Food and Drug Administration’s (FDA’s) Office of Generic Drugs recently issued a revised Manual of Policies and Procedures (MAPP) describing the agency’s internal procedures for handling generic drug labeling changes, including listing the responsibilities of the internal FDA staff responsible for managing these labeling changes.   The 16-page MAPP implements Section 10609 the Patient Protection and Affordable Care Act (PPACA) which was enacted in 2010 and add...